Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Psychiatric Patients

Completed

• Conditions: Cognitive Functions Confusion; Suicidal Behaviour
• Interventions: Other: Interview questionnaire; Diagnostic Test: biochemical parameters; Diagnostic Test: cognitive function

• Registration Number: NCT05803447
• Lead Sponsor: Medical University of Bialystok

Brief Summary

The aim of this study was to analyse the level of cognitive functioning of patients with history of suicidal behaviour suffering from depression and schizophrenia, and to evaluate their oxidative stress parameters and selected biochemical parameters on the basis of bloodwork.

Detailed Description

The study was conducted among 120 patients hospitalized in the Department of Psychiatry of the UMB (Medical University of Białystok). Every participant gave their own voluntary and informed written consent. Blood parameters tests were performed in the Diagnostic Laboratory of the University's Clinical Hospital and in the Department of Hygiene, Epidemiology and Ergonomics of the Medical University of Białystok. In the first stage of the study, an M.I.N.I. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour. Based on the scores, the patients were classified into one of eight groups: no suicidal behaviour group (G0K, G0M); group experiencing suicidal thoughts without a tendency of implementation (G1K, G1M); group experiencing suicidal thoughts with a tendency of implementation (G2K, G2M); group after a suicide attempt (G3K, G3M).The second stage of the study consisted of biochemical blood tests, where concentrations of vitamin D3, B12, folic acid, sodium, potassium, calcium, magnesium, chlorine, total cholesterol, LDL and HDL fractions, TG and metabolites of the oxidative stress pathway were determined. The following concentrations were determined: dityrosine (AUF/mg protein), TOS (nmol H2O2 Equiv/mg protein), TAC (umol/mg protein), OSI (TOS/TAC ratio), FRAP (μmol/mg protein), GPx (mU/mg protein), SOD (mU/mg protein) CAT (nmol H2O2/min/mg protein), AOPP (nmol/mg protein), NO (nmol/mg protein), GSH (μg/mg protein). The third stage of the study consisted of the participants completing a CogState computerized test to verify their cognitive functioning. The following cognitive functions were assessed: psychomotor drive (DET), metastability of attention (IDN), verbal memory, retrieval of learned material (ISLR) and verbal learning and memory (ISL), visual learning and memory (OCL), processing speed (GMCT), visual memory including deferred retrieval (GMR), executive functions (SETS and GML), working memory (ONB, TWOB).

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted: 2023-01-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients of clinical psychiatry
• patients diagnosed with schizophrenia and depression
• age: 20-50 years
• gender: women and men

Exclusion Criteria

• exclusion criteria were any present major medical illness (somatic or neurological disease)
• use of psychoactive substances
• decreased level of cognitive functioning
• people who do not use a computer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G3M-men	biochemical parameters	The G3M group consisted of men after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=17)
G3M-men	cognitive function	The G3M group consisted of men after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=17)
G1K-women	Interview questionnaire	The G1K group consisted of women experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=14)
G2M-men	biochemical parameters	The G2M group consisted of men experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=9)
G0M-men	Interview questionnaire	The G0M group consisted of men displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=20)
G0M-men	biochemical parameters	The G0M group consisted of men displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=20)
G1K-women	biochemical parameters	The G1K group consisted of women experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=14)
G1K-women	cognitive function	The G1K group consisted of women experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=14)
G1M-men	Interview questionnaire	The G1M group consisted of men experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=16)
G2K-women	biochemical parameters	The G2K group consisted of women experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=19)
G2K-women	cognitive function	The G2K group consisted of women experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=19)
G2M-men	cognitive function	The G2M group consisted of men experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=9)
G1M-men	cognitive function	The G1M group consisted of men experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=16)
G1M-men	biochemical parameters	The G1M group consisted of men experiencing suicidal thoughts without a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 1 to 8 points (n=16)
G2K-women	Interview questionnaire	The G2K group consisted of women experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=19)
G2M-men	Interview questionnaire	The G2M group consisted of men experiencing suicidal thoughts with a tendency of implementation, in whom the result of M.I.N.I. 7.0.2 test was 9 to 16 points (n=9)
G3K-women	Interview questionnaire	The G3K group consisted of women after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=15)
G3K-women	cognitive function	The G3K group consisted of women after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=15)
G3M-men	Interview questionnaire	The G3M group consisted of men after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=17)
G0K-women	Interview questionnaire	The G0K group consisted of women displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=10)
G0K-women	cognitive function	The G0K group consisted of women displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=10)
G3K-women	biochemical parameters	The G3K group consisted of women after a suicide attempt, in whom the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points (n=15)
G0K-women	biochemical parameters	The G0K group consisted of women displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=10)
G0M-men	cognitive function	The G0M group consisted of men displaying no suicidal behaviour, in whom the result of M.I.N.I. 7.0.2 test was zero points (n=20)

Primary Outcome Measures

Name	Time	Method
At the first stage, the participants were interviewed by the certified clinical psychologist. M.I.N.I. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour.	in the first 48 hours after the hospital admission	The setting of the study assumed that the procedure started in the first 48 h after the hospital admission. Based on the scores M.I.N.I.7.0.2 the patients were classified into one of eight groups: * control groups displaying no suicidal behaviour (G0K - women and G0M - men), the result of M.I.N.I. 7.0.2 test was zero points; * groups experiencing suicidal thoughts without a tendency of implementation (G1K - women and G1M - men), the result of M.I.N.I. 7.0.2 test was 1 to 8 points; * groups experiencing suicidal thoughts with a tendency of implementation (G2K - women and G2M - men), the result of M.I.N.I. 7.0.2 test was 9 to 16 points; * groups after a suicide attempt (G3K - women and G3M - men), the result of M.I.N.I. 7.0.2 test was equal to or greater than 17 points.

Secondary Outcome Measures

Name	Time	Method
The second stage of the study consisted of biochemical blood tests - oxidative stress	1 week	The another laboratory tests were performer to determine parameters of oxidative stress.; The following concentrations were determined: dityrosine (AUF/mg protein), TOS (nmol H2O2 Equiv/mg protein), TAC (umol/mg protein), OSI (TOS/TAC ratio), FRAP (µmol/mg protein), GPx (mU/mg protein), SOD (mU/mg protein) CAT (nmol H2O2/min/mg protein), AOPP (nmol/mg protein), NO (nmol/mg protein), GSH (µg/mg protein).; The obtained plasma was precooled in liquid nitrogen and stored at -80°C. Tests were made using a Sigma-Aldrich device, using 96 well microplate reader (InfiniteM200 PROMultimode Tecan; Tecan Group Ltd) absorbance/fluorescence of the plates was measured. The results were standardized to 1 mg proteins and the measurements were performed on two samples to verify the results.
The second stage of the study consisted of biochemical blood tests - vitamins	1 week	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. In the next phase, some of the test tubes used to determine the concentration of vitamins (vitamin D3, B12, folic acid) were immediately used to perform these determinations standard method used in the hospital laboratory USK in Bialystok. The laboratory used Abbott equipment to perform these determinations (Architect 25-OH Vitamin D, Architect i System, Architect Follate).
The second stage of the study consisted of biochemical blood tests - total cholesterol, LDL, HDL, TG	1 week	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. The remaining tubes were placed in a freezer at -17 to -12°C, and after 24 hours the samples were stored at the temperature of -80° C in which they were stored until being assayed (total cholesterol, LDL, HDL, TG). Total cholesterol and serum HDL cholesterol remained determined by the enzymatic-colorimetric method. The LDL cholesterol level was calculated from the formula Friedewald.
The second stage of the study consisted of biochemical blood tests - ions	1 week	Venous blood (10 mL) was collected from all patients, then were left at room temperature for 30-60 minutes to separate the serum. After that the blood was centrifuged at 4500 x g for 20 min at 4 °C. In the next phase, some of the test tubes used to determine the concentration of ions (calcium, magnesium, chlorine, sodium, potassium) were immediately used to perform these determinations standard method used in the hospital laboratory USK in Bialystok. The laboratory used Abbott Alnity c equipment to perform these determinations. The remaining tubes were placed in a freezer at -17 to -12°C, and after 24 hours the samples were stored at the temperature of -80° C in which they were stored until being assayed (total cholesterol, LDL, HDL, TG).